Z-1775-2022 Class II Ongoing
FDA device recall Z-1775-2022 was initiated by Covidien Llc on Aug 19, 2022 and is designated Class II. Reason for recall: Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components. The recall status is ongoing. Affected quantity: 5 US.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 28, 2022
- Initiation Date
- Aug 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 US
Product Description
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Reason for Recall
Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.
Distribution Pattern
Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
Code Information
UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1775-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026